WASHINGTON _ At the request of the Food and Drug Administration, the drug

company that produces the experimental AIDS drug DDC has established two

programs to fill the void created by the lack of DDC on the underground market,

FDA officials said Saturday.

Recently, the agency discovered that the DDC being sold by illegal ``buyer's

clubs'' varied considerably in strength from the doses thought to be most

effective and urged the clubs to discontinue selling it _ which they are

believed to have done.

FDA officials, who have exercised a hands-off attitude toward the illegal

clubs _ because they appreciate the desperation of those seeking the therapies

believed that some action was needed to replenish the supply for patients

unable to obtain the drug, which is being developed by Hoffmann-La Roche, Inc.,

of Nutley, N.J.

The new programs will allow DDC to be given together with AZT, another

antiviral AIDS drug, a combination which has been shown in limited studies to

have a more beneficial effect on the immune system than AZT alone.

``Roche is committed to helping people in the AIDS community,'' said Dr.

Whaijen Soo, the company's senior director of clinical virology and AIDS

research. ``These programs represent a dramatic step in providing access to a

promising AIDS therapy.''

The drug company already has a program of expanded access for the drug, but

only for patients who take DDC alone because they cannot medically tolerate AZT.

In recent years, the FDA has relaxed its rules regarding the use of

experimental AIDS drugs to allow individuals greater access to them while they

are still being studied.

``We appreciate that the buyer's clubs worked with us to maintain the good

quality of the drugs they were selling and we applaud Hoffmann-La Roche for

coming in to fulfill an important need,'' FDA Commissioner David A. Kessler

said Saturday.

Both programs will remain under a large-scale research umbrella, that is,

information gleaned from them will be used by federal health officials to

evaluate the efficacy of the drug. The company has already applied for

marketing approval.

The first program, slated to begin within two weeks, will provide DDC to two

groups of individuals infected with the human immunodeficiency virus who wish

to take the combination therapy.

These include those who already have experienced symptoms of disease and

have CD4 cell counts of 300 or fewer, and those with CD4 counts of 200 or fewer

who have not yet exhibited symptoms.

CD4 cells, also known as T helper cells, are the primary target of HIV. In

healthy individuals, a normal CD4 count ranges between 800 and 1,200. As these

critical immune system cells are destroyed, the body becomes prone to a range

of life-threatening infections and other serious conditions.

DDC and AZT together have been shown, in small studies, to increase the

level of CD4 cells for higher levels and for longer periods of time than AZT

alone.

The second program, a so-called ``large simple trial,'' will involve an

estimated 10,000 to 15,000 healthier HIV-infected individuals _ those with CD4

counts of up to 500. It will use combination AZT-DDC therapy but will compare

different doses of DDC _ a high dose vs. a low dose.

This study will take a little longer to design and implement, FDA officials

said. It also likely will involve input from the National Institutes of Health,

which sponsors the most extensive network of research involving AIDS drugs.

``The company is looking for a partner in this study,'' said Dr. David

Feigal, director of the FDA's division of antiviral drugs. ``They have

initiated conversations with NIH but exactly who will do it remains to be

seen.''

Feigal said that the only individuals who might continue to have difficulty

obtaining DDC are those with CD4 cell counts higher than 500 who want to take

the combination therapy.